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Advice on preventive dental care for children, prior to 1900 is scarce. In the 1890s, Drs. Morrison and Henry, two Punxsutawny, Pennsylvania dentists, cogently offered such advice in their promotional pamphlet, along with some lessons on life, as reflected by precious stones.
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Folletos , Pennsylvania , Historia del Siglo XIX , Humanos , Folletos/historia , Odontología Preventiva/historia , Atención Dental para Niños/historia , Niño , Odontólogos/historiaRESUMEN
This study is a randomized controlled interventional study aimed to determine the effect of preoperative brochure-assisted education on surgical fear and anxiety in patients scheduled for septorhinoplasty surgery. The study was conducted between May 2022 and February 2023 in the Otorhinolaryngology services and clinics of a training and research hospital in the southern region of Turkey. The study included 61 patients, with 29 in the education group and 32 in the control group. All patients received routine nursing care before surgery, with the education group receiving additional education through an informative brochure. The data were collected using the "Personal Information Form", "Surgical Fear Questionnaire", and "Surgical Anxiety Questionnaire". There was no significant difference in the mean scores of surgical fear between the groups on the morning of the surgery (p > 0.05). However, a significant difference was found in the mean scores of surgical anxiety between the groups (p < 0.05). In conclusion, patients in the education group who received preoperative brochure-assisted education had lower anxiety compared with the control group.
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Ansiedad , Miedo , Folletos , Educación del Paciente como Asunto , Humanos , Masculino , Femenino , Turquía , Ansiedad/psicología , Ansiedad/prevención & control , Adulto , Miedo/psicología , Encuestas y Cuestionarios , Educación del Paciente como Asunto/métodos , Educación del Paciente como Asunto/normas , Persona de Mediana Edad , Rinoplastia/psicología , Rinoplastia/métodosRESUMEN
Effective medication management poses significant challenges, particularly when navigating multiple medications with intricate dosages and schedules. This paper presents a prototype mobile application to streamline information retrieval from dense medication leaflets. By utilizing automated information extraction based on large language models, the application seamlessly retrieves pertinent details from the Austrian medicinal product index upon scanning the medication package. This extracted information is organized and displayed within the app, ensuring clarity and accessibility for users. In addition to this core functionality, the application offers a suite of features tailored to facilitate effective medication management. By integrating comprehensive medication information with practical medication management tools, the application empowers users to navigate complex medication regimes with confidence and ease.
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Aplicaciones Móviles , Inteligencia Artificial , Humanos , Austria , Folletos , Etiquetado de Medicamentos , Procesamiento de Lenguaje NaturalRESUMEN
OBJECTIVE: To compare the reliability, usability, and efficiency of video versus print instructions to teach parents a procedural measurement task. We hypothesized that videos would outperform print in all outcomes. STUDY DESIGN: This cross-sectional study included parents/caregivers of children aged 0-18 years with deep vein thrombosis attending the Thrombosis Clinic at The Hospital for Sick Children for post-thrombotic syndrome (PTS) assessment. Participants were randomly assigned to three instruction types: (i) video, which followed the technique used by clinicians; (ii) long pamphlet, which also followed the clinicians' technique; and (iii) short pamphlet, which explained a simplified technique. After measuring their children's arms or legs using the randomly assigned material, participants completed a usability questionnaire. The reliability of the instructions was estimated by comparing parents/caregivers versus clinicians' measurements using the intraclass correlation coefficient (ICC). Reliability, usability, and efficiency (time to task completion) were compared among the three instruction types. RESULTS: In total, 92 participants were randomized to video (n = 31), long pamphlet (n = 31), and short pamphlet (n = 30). While the video had the highest usability, the short pamphlet was the most reliable and efficient. ICCs were .17 (95% confidence interval [CI]: .00-.39) for the video, .53 (95% CI: .30-.72) for the long pamphlet, and .70 (95% CI: .50-.81) for the short pamphlet. CONCLUSION: Although the video had higher usability, the short/simplified print instruction was more reliable and efficient. However, the reliability of the short pamphlet was only moderate/good, suggesting that whenever possible, measurements should still be obtained by trained clinicians.
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Padres , Humanos , Estudios Transversales , Femenino , Padres/educación , Masculino , Niño , Preescolar , Lactante , Adolescente , Recién Nacido , Reproducibilidad de los Resultados , Adulto , Trombosis de la Vena , Folletos , Grabación en Video , Educación del Paciente como Asunto/métodos , Encuestas y CuestionariosRESUMEN
AIMS: The aims of this research include adapting a patient information tool for whanau (extended family) Maori needs, identifying and reviewing written information provided for the retinopathy of prematurity eye examination (ROPEE) and identifying improvements to ROPEE written information. METHODS: ROPEE patient information (printed leaflets, website, app) was obtained from all tertiary neonatal intensive care units in Aotearoa New Zealand (Aotearoa). Information was reviewed using an adapted "20 good-design principles" guide and given a star rating and Flesch-Kincaid readability score to identify acceptability and usability for patients. RESULTS: Seven ROPEE information materials were reviewed and varied in alignment with the adapted good-design principles tool. Based on the adapted good-design principles, opportunities were identified in many aspects of the written information for improvement, including words and language, tone and meaning, content and design. The Flesch-Kincaid grade level reading scores ranged from 12-22 years reading age. Written information also did not use te reo Maori (Aotearoa Indigenous language) or extensively use Maori imagery. CONCLUSION: Opportunities exist to improve ROPEE whanau information, including making content more readable, understandable and visually appealing. Optimising the clinical information on ROPEE nationally for Aotearoa will support whanau decision making, and aligning written information with Maori (Indigenous peoples of Aotearoa) is a priority.
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Retinopatía de la Prematuridad , Humanos , Recién Nacido , Recien Nacido Prematuro , Unidades de Cuidado Intensivo Neonatal , Nueva Zelanda , Folletos , Educación del Paciente como Asunto/métodos , Retinopatía de la Prematuridad/diagnósticoRESUMEN
BACKGROUND: Incorporating video as a tool for education offers a multitude of advantages. However, it is unknown what is the best educational tool to use for increasing public awareness, consequently reducing fear about root canal treatment. For this reason, this study aimed to compare the effectiveness of educational animation and leaflets as delivery methods for providing information on root canal treatment to patients and to assess their ability to retain the information. METHODS: One hundred fifty adult volunteers were recruited via social media and Umm Al-Qura University Dental Hospital to participate in this randomized control trial study. The volunteers were divided into the study group (SG) and the control group (CG). The SG was provided with information through animations created by the research team, while the CG received the same information through a leaflet. Pre-intervention (T1), immediate post-intervention (T2), and one-month post-intervention (T3) validated questionnaires were completed by the participants to assess the changes in their knowledge. To evaluate the impact of the information delivery method, the knowledge scores of T2 and T3 were compared to T1 within each group using Paired T-tests. Additionally, the study compared the knowledge scores of the two groups using unpaired T-tests. The significance level was set at a P-value of less than 0.05. RESULTS: A significant improvement in endodontic therapy knowledge among the participants in both groups (T1 compared to T2 in the same group) was noted (P < 0.050). However, when comparing T2 between groups, no significant difference was found in delivering the information and improving the knowledge (P = 0.080). Still, the mean differences between T1 and T2, as well as T1 and T3, were greater (P < 0.050) in the SG than in the CG. Furthermore, the total knowledge score in the SG at T3 was significantly higher than the CG. CONCLUSION: Both educational animation and leaflets are practical tools to increase patients' awareness about root canal treatment. However, educational videos are more effective than leaflets in delivering and retaining information about root canal treatment. TRIAL REGISTRATION: This study was retrospectively registered as a randomized control trial at the ISRCTN registry with the document number ISRCTN18413241, 15/05/2023.
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Conocimientos, Actitudes y Práctica en Salud , Folletos , Educación del Paciente como Asunto , Tratamiento del Conducto Radicular , Humanos , Tratamiento del Conducto Radicular/métodos , Masculino , Femenino , Adulto , Educación del Paciente como Asunto/métodos , Persona de Mediana Edad , Adulto Joven , Grabación en VideoRESUMEN
Folhedo informativo sobre a taturana (lonomia oblíqua)
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Mariposas Nocturnas , Folletos , Manifestaciones CutáneasRESUMEN
Folheto educativo referente à barata: biologia, medidas preventivas e importância para a saúde
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Cucarachas , Educación en Salud , Atención Primaria de Salud , FolletosRESUMEN
Folhedo informativo sobre o abelhas e vespas
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Abejas , Avispas , Hipersensibilidad al Veneno/prevención & control , Atención Primaria de Salud , FolletosRESUMEN
BACKGROUND: Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback. METHODS: We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase. RESULTS: Two hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases. CONCLUSIONS: Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice.
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Comprensión , Juego de Azar , Folletos , Educación del Paciente como Asunto , Sujetos de Investigación , Humanos , Juego de Azar/psicología , Irlanda , Sujetos de Investigación/psicología , Educación del Paciente como Asunto/métodos , Conocimientos, Actitudes y Práctica en Salud , Autoinforme , Reino Unido , Femenino , Alfabetización en Salud , Masculino , Consentimiento Informado , Ensayos Clínicos como Asunto/métodos , Persona de Mediana Edad , Adulto , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
You and Your Baby was a pregnancy advice booklet, produced by the British Medical Association (BMA) from 1957-1987. This booklet was provided to expectant mothers in the UK, free of charge, and offered authoritative information on pregnancy, childbirth and caring for infants. Reprinted each year, You and Your Baby captured contemporary maternity policy and advice. But, in addition to the typical information that you might expect about mother and baby health, You and Your Baby advised readers on matters such as maintaining their appearance, marital relations and domestic duties. In this way, it advocated a specific vision of motherhood, with responsibilities to the home and husband. Further to these duties, this article will focus on the balance of responsibilities between pregnant women and their doctors, and how attitudes to trust and authority developed over time. The BMA publication repeatedly warned readers against listening to 'old wives' tales', instead emphasising the importance of accepting (and not questioning) professional medical guidance. Following the thalidomide scandal, however, women were made partially responsible for doctors' professional integrity; women were advised to avoid asking their doctors to prescribe medication that may later prove to be harmful, shifting the responsibility from the healthcare practitioner to the mother. This created an uncomfortable dissonance between the publication's attempts to establish and reinforce medical authority, and yet shift professional responsibility. The booklet series, therefore, posed women as responsible for their doctors, as well as their babies. In summary, this article presents a case study of the You and Your Baby BMA booklet, examining developing healthcare messaging around maternal behaviour and responsibility. It draws attention to supposed responsibilities to the home, husband and doctor and how those responsibilities changed over 30 years.
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Madres , Folletos , Esposos , Humanos , Femenino , Embarazo , Reino Unido , Esposos/psicología , Madres/psicología , Historia del Siglo XX , Sociedades Médicas/historia , Talidomida/historia , Médicos/historia , Responsabilidad SocialRESUMEN
BACKGROUND: Blood stasis (BS) refers to a pattern of symptoms resulting from circulatory dysfunction or stagnation in the human body. Due to its historical origin and diverse interpretations, communication between patients and doctors of traditional Korean medicine (DKMs) presents challenges. Efforts to improve patients understanding in traditional Korean medicine (TKM) have led to the development of disease-specific standard clinical practice guidelines. However, there is a limited focus on creating clinical practice guidelines or informative leaflet specifically addressing BS, which is a frequently encountered pattern of symptoms in TKM. METHODS: This study aimed to bridge the gap between patients and DKMs by developing an informative leaflet focusing on BS for metabolic diseases. We assessed its appropriateness through expert advisory meetings and the Delphi process, and evaluated its clinical effectiveness. We conducted a prospective, randomized, crossover trial to compare the clinical effectiveness of using BS leaflets in TKM treatment. The hypothesis investigated whether the leaflet group would show higher scores in satisfaction of DKMs' explanations, understanding of DKMs' explanations, improving the reliability of TKM, satisfaction with treatment time, improvement in explanations compared to previous TKM experiences, and necessity of managing BS treatment, compared to the no-leaflet group. RESULTS: In a study involving 40 patients (mean age: 62.3â ±â 7.8 years), symptoms persisted for an average of 16.75â ±â 9.3 hours daily, with a severity rating of 2.53. The leaflet group exhibited significantly higher satisfaction scores than the no-leaflet group in all aspects (all Pâ <â .0001). After confirming the absence of sequence and period effects using a linear-mixed effect model, we were able to ascertain the presence of a treatment effect, as evidenced by statistically significant higher scores across all survey items in the leaflet group compared to the no-leaflet group (all Pâ <â .0001). CONCLUSION: Expert consensus on symptoms aligning with the BS pattern resulted in the development of an informative leaflet. Its utilization notably improved patient satisfaction, comprehension, and trust in TKM treatment, unaffected by temporal influences, thus demonstrating its clinical effectiveness. In summary, the BS leaflet significantly enhanced patient understanding and optimized treatment procedures.
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Estudios Cruzados , Medicina Tradicional Coreana , Humanos , Femenino , Estudios Prospectivos , Masculino , Persona de Mediana Edad , Medicina Tradicional Coreana/métodos , Anciano , Satisfacción del Paciente , Folletos , Resultado del TratamientoRESUMEN
BACKGROUND: Retaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are developed at the planning stage, i.e. post-funding during protocol development, but some protocols include strategies for participant retention as retention is considered and planned for early in the trial planning stage. It is yet unknown if these plans are communicated in the corresponding participant information leaflets (PILs). The purpose of our study was to determine if PILs communicate plans to promote participant retention and, if so, are these outlined in the corresponding trial protocol. METHODS: Ninety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate. RESULTS: Plans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use "combined strategies" to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies). CONCLUSION: Retention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL.
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Folletos , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Adulto , Comunicación , Selección de Paciente , Sujetos de Investigación/psicología , Educación del Paciente como Asunto/métodos , Protocolos de Ensayos Clínicos como Asunto , Conocimientos, Actitudes y Práctica en Salud , Reino Unido , Proyectos de Investigación , Pacientes Desistentes del TratamientoRESUMEN
These recommended tips can be set up as free-of-charge, attractive pamphlets, which can either be given to the veterinary patient's owner when medications are supplied or made available as a display.
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Drogas Veterinarias , Animales , Humanos , Medicina Veterinaria/normas , FolletosRESUMEN
BACKGROUND: Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs). METHODS: A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third. RESULTS: Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas. CONCLUSION: Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.
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Ensayos Clínicos como Asunto , Consentimiento Informado , Folletos , Educación del Paciente como Asunto , Sujetos de Investigación , Humanos , Ensayos Clínicos como Asunto/ética , Medición de Riesgo , Irlanda , Reino Unido , Formularios de Consentimiento/normas , Factores de Riesgo , Conocimientos, Actitudes y Práctica en Salud , Autonomía Personal , ComprensiónRESUMEN
Advances in the multiphase optimization strategy (MOST) have suggested a new approach, decision analysis for intervention value efficiency (DAIVE), for selecting an optimized intervention based on the results of a factorial optimization trial. The new approach opens possibilities to select optimized interventions based on multiple valued outcomes. We applied DAIVE to identify an optimized information leaflet intended to support eventual adherence to adjuvant endocrine therapy for women with breast cancer. We used empirical performance data for five candidate leaflet components on three hypothesized antecedents of adherence: beliefs about the medication, objective knowledge about AET, and satisfaction with medication information. Using data from a 25 factorial trial (n = 1603), we applied the following steps: (i) We used Bayesian factorial analysis of variance to estimate main and interaction effects for the five factors on the three outcomes. (ii) We used posterior distributions for main and interaction effects to estimate expected outcomes for each leaflet version (32 total). (iii) We scaled and combined outcomes using a linear value function with predetermined weights indicating the relative importance of outcomes. (iv) We identified the leaflet that maximized the value function as the optimized leaflet, and we systematically varied outcome weights to explore robustness. The optimized leaflet included two candidate components, side-effects, and patient input, set to their higher levels. Selection was generally robust to weight variations consistent with the initial preferences for three outcomes. DAIVE enables selection of optimized interventions with the best-expected performance on multiple outcomes.
Intervention optimization involves using data from an optimization trial to select the combination of intervention components that are expected to successfully balance effectiveness (i.e. improving an outcome in the desired direction) with efficiency (i.e. producing a good outcome without wasting resources). Recently, a new method for selecting optimized interventions has been proposed that has a number of advantages, including the ability to use empirical information about more than one outcome variable of interest. Here, we applied this new method to identify an optimized information leaflet designed to support eventual medication adherence in women with breast cancer, using empirical information about three outcome variables that are thought to be important for later medication adherence: beliefs about the medication, objective knowledge about the medication, and satisfaction with the leaflet information. When we let beliefs about the medication be most important; knowledge about the medication to be half as important as beliefs; and satisfaction with information to be half as important as knowledge, the optimized leaflet included enhanced information about side-effects and photos and quotes from women with breast cancer. This decision remained generally the same when we systematically varied the weights used to give outcomes their relative importance.
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Teorema de Bayes , Neoplasias de la Mama , Toma de Decisiones , Técnicas de Apoyo para la Decisión , Cumplimiento de la Medicación , Humanos , Femenino , Neoplasias de la Mama/tratamiento farmacológico , Educación del Paciente como Asunto/métodos , Persona de Mediana Edad , Folletos , Conocimientos, Actitudes y Práctica en Salud , Satisfacción del Paciente , Antineoplásicos Hormonales/uso terapéutico , Antineoplásicos Hormonales/administración & dosificaciónRESUMEN
BACKGROUND: home exercise booklets offer several benefits to individuals with shoulder pain. However, it is necessary to investigate the factors that determine adherence to home exercises. OBJECTIVES: 1) To investigate the level of adherence of individuals with chronic shoulder pain to a home exercise booklet conducted without the mediation of a healthcare professional, 2) To describe the barriers and facilitators to adherence, and 3) to determine if shoulder disability, self-efficacy, and treatment expectations are predictors of the level of adherence. DESIGN: prospective longitudinal study. METHODS: A total of 47 individuals with chronic shoulder pain were recruited. The Numeric Pain Rating Scale (NPRS) was used to assess pain intensity, the Shoulder Pain and Disability Index (SPADI) to measure shoulder disability, the Pain Self-Efficacy Questionnaire (PSEQ-10) for self-efficacy, and a likert scale to measure treatment expectations. Adherence was measured by Exercise Adherence Assessment Scale (EAAE-Br). RESULTS: A total of 23 individuals (48.93%) adhered to the home exercise program. The most commonly cited barriers were pain and health-related issues, while the most cited facilitators were pain improvement and symptom relief. Barriers associated with adherence were time constraints and other commitments, while the facilitator associated with adherence was enjoying the exercises. Binary logistic regression analysis revealed that shoulder disability, self-efficacy, and treatment expectations were unable to predict adherence to home exercises in individuals with shoulder pain [F (1,47) = 2.384; p = 0.130; R2 = 0.056]. CONCLUSION: The study revealed barriers and facilitators to home exercise in individuals with shoulder pain. Disability, self-efficacy, and treatment expectations were not able to predict adherence.
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Terapia por Ejercicio , Cooperación del Paciente , Autoeficacia , Dolor de Hombro , Humanos , Masculino , Femenino , Persona de Mediana Edad , Dolor de Hombro/terapia , Dolor de Hombro/psicología , Estudios Prospectivos , Terapia por Ejercicio/métodos , Adulto , Cooperación del Paciente/estadística & datos numéricos , Cooperación del Paciente/psicología , Estudios Longitudinales , Anciano , Folletos , Dimensión del Dolor , Encuestas y Cuestionarios , Evaluación de la DiscapacidadRESUMEN
INTRODUCTION: Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has not been explored. Patient information leaflets (PILs) are a core component of the informed consent process. This study aimed to investigate the key content of PILs for recently completed placebo-controlled trials of invasive procedures, including surgery, to highlight areas of good practice, identify gaps in information provision for trials of this type and provide recommendations for practice. METHODS: PILs were sought from trials included in a recent systematic review of placebo-controlled trials of invasive procedures, including surgery. Trial characteristics and data on surgical and placebo interventions under evaluation were extracted. Directed content analysis was applied, informed by published regulatory and good practice guidance on PIL content and existing research on placebo-controlled surgical trials. Results were analysed using descriptive statistics and presented as a narrative summary. RESULTS: Of the 62 eligible RCTs, authors of 59 trials were contactable and 14 PILs were received for analysis. At least 50% of all PILs included content on general trial design. Explanations of how the placebo differs or is similar to the surgical intervention (i.e. fidelity) were reported in 6 (43%) of the included PILs. Over half (57%) of the PILs included information on the potential therapeutic benefits of the surgical intervention. One (7%) included information on potential indirect therapeutic benefits from invasive components of the placebo. Five (36%) presented the known risks of the placebo intervention, whilst 8 (57%) presented information on the known risks of the surgical intervention. A range of terms was used across the PILs to describe the placebo component, including 'control', 'mock' and 'sham'. CONCLUSION: Developers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar) to the surgical intervention and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials.
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Consentimiento Informado , Folletos , Educación del Paciente como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Procedimientos Quirúrgicos Operativos , Humanos , Consentimiento Informado/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Procedimientos Quirúrgicos Operativos/normas , Procedimientos Quirúrgicos Operativos/efectos adversos , Efecto Placebo , Proyectos de Investigación/normas , Placebos , ComprensiónRESUMEN
BACKGROUND: The New Medicine Service (NMS) was developed in England more than ten years ago, as a three-stage consultation led by community pharmacists to support patients taking new medication for a chronic disease. In Poland, the scheme was officially introduced in January 2023. However, its implementation into common practice has been presented with various obstacles, including the need to develop relationships with general practitioners, resolve the payment structure, and provide training with adequate supporting materials. Hence, written materials have been designed for use as an optional tool for counselling patients receiving an NMS in community pharmacies. METHODS: The present study evaluates the ability of these materials to inform patients about the need to adhere to anti-hypertensive medication. A group of 401 randomly-selected adult visitors to pharmacies and/or healthcare centres were surveyed; one third had hypertension in their history. RESULTS: The structure, grammar and readability of the text achieved the required threshold of 40% according to the Plain Language Index. The designed materials effectively informed the patients about anti-hypertensive medication, reflected in an increased score in a knowledge test, and were rated positively regarding information level, comprehensibility and presentation. CONCLUSION: The proposed material may serve as an additional, "patient-friendly" educational tool for use as part of an NMS.
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Consejo , Hipertensión , Educación del Paciente como Asunto , Humanos , Polonia , Hipertensión/tratamiento farmacológico , Hipertensión/terapia , Masculino , Femenino , Persona de Mediana Edad , Adulto , Antihipertensivos/uso terapéutico , Folletos , Cumplimiento de la Medicación , Servicios Comunitarios de Farmacia/organización & administración , AncianoRESUMEN
INTRODUCTION: Critical limb-threatening ischemia (CLTI) is associated with a high risk of amputation, yet patients undergoing amputation due to CLTI have little knowledge of the amputation process and the rehabilitation that awaits. The aim of the present study was to develop and validate information material for patients undergoing amputation. METHODS: Nine participants were included in the study. Two focus group interviews were performed with seven patients who had undergone lower extremity amputation due to CLTI within the past 2 y. Additionally, two individual interviews were carried out. A semistructured interview guide was used, and the interviews were transcribed verbatim and analysed using qualitative content analysis with a deductive approach. RESULTS: Three themes were identified as essential for the design of the written information: Perspectives on design and formatting, Providing information to enhance participation in care, and Accessibility to information and support. The prototyped information leaflet was perceived as acceptable, useable, relevant, and comprehensible by the participants. CONCLUSIONS: For patients to actively engage in their care, it is vital that their information needs are met and that they are provided with psychosocial support when needed. Written and oral information should be provided by a trusted healthcare professional.